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Treatment of ADHD with care as usual versus an elimination diet


- candidate number22942
- NTR NumberNTR5434
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-okt-2015
- Secondary IDs2014-1349 local CMO Arnhem-Nijmegen
- Public TitleTreatment of ADHD with care as usual versus an elimination diet
- Scientific TitleTreatment of ADHD with care as usual versus an elimination diet
- ACRONYMTRACE
- hypothesisTreatment of ADHD with an elimination diet is more (cost-)effective than the care as usual after 1.5 years
- Healt Condition(s) or Problem(s) studiedADHD, Diet, Intervention
- Inclusion criteria- children, age 5-12 years
- diagnosis for ADHD, any sub-type, according to DSM V
- clinical diagnosis for ADHD confirmed by information from parents and school teacher
- Exclusion criteria- use of psychotropic medication or a strict (elimination) diet
- children who have received treatment for ADHD in the past two months
- children who are diagnosed with diabetes melitus
- children who are diagnosed with an eating disorder
- children with an inadequate mastery of the Dutch language
- children who require therapy from the care as usual immediately (e.g. in case of parent-child relationship problems)
- children who refuse to have meat or animal food products in general in their diet (e.g., vegetarian, vegan)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 29-sep-2015
- planned closingdate1-dec-2019
- Target number of participants301
- Interventions1. care as usual
Diet interventions:
2. eliminating major allergens/triggers
3. balanced diet
- Primary outcomeADHD symptoms
- Secondary outcome- cognitive performance
- motor activity
- school performance
- direct and indirect costs
- Timepointsthree timepoints:
1. baseline
2. after 5 weeks of treatment
3. after 1.5 years of treament
- Trial web sitehttp://www.project-trace.nl/
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESPostdoctoral researcher and psychologist Verena Ly
- CONTACT for SCIENTIFIC QUERIESPostdoctoral researcher and psychologist Verena Ly
- Sponsor/Initiator Karakter kinder- en jeugdpsychiatrie
- Funding
(Source(s) of Monetary or Material Support)
Innovatiefonds zorgverzekeraars, ZonMw DoelmatigheidsOnderzoek Type I Program
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD5-okt-2015 - 18-nov-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl